An Open Label, Dose Titration Study of Sevelamer Carbonate Tablets & Powder in Hyperphosphatemic CKD Patients

NCT ID: NCT02332811

Last Updated: 2016-12-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-10-31
• Study Completion Date: 2014-07-31

Brief Summary

Primary Objective:

Evaluate the reduction in serum phosphorus from baseline to end of study with Sevelamer carbonate tablets 800 mg and Sevelamer carbonate Powder 2.4 g in chronic kidney disease (CKD) patients both on haemodialysis and not on dialysis

Secondary Objective:

Evaluate the safety on the basis of adverse events, changes in laboratory values and vital signs from baseline (Day 0) to Day 56 (End of treatment/ End of Study)

Detailed Description

10 weeks including, 2 weeks wash-out period and 8 weeks study treatment period

Conditions

Renal Failure Chronic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CKD patients not on dialysis 800 mg

Sevelamer carbonate 800 mg in tabs 3 times per day with meals

Group Type: EXPERIMENTAL

sevelamer carbonate 800mg

Intervention Type: DRUG

Pharmaceutical form:tablet

Route of administration: oral

CKD patients not on dialysis 2.4 g

Sevelamer carbonate 2.4 g powder carbonate per day

Group Type: EXPERIMENTAL

sevelamer carbonate 2.4 g

Intervention Type: DRUG

Pharmaceutical form:powder

Route of administration: oral

CKD patients on dialysis 800 mg

Sevelamer carbonate 800 mg in tabs 3 times per day with meals

Group Type: EXPERIMENTAL

sevelamer carbonate 800mg

Intervention Type: DRUG

Pharmaceutical form:tablet

Route of administration: oral

CKD patients on dialysis 2.4 g

Sevelamer carbonate 2.4 g powder carbonate per day

Group Type: EXPERIMENTAL

sevelamer carbonate 2.4 g

Intervention Type: DRUG

Pharmaceutical form:powder

Route of administration: oral

Interventions

sevelamer carbonate 800mg

Pharmaceutical form:tablet

Route of administration: oral

Intervention Type: DRUG

sevelamer carbonate 2.4 g

Pharmaceutical form:powder

Route of administration: oral

Intervention Type: DRUG

Other Intervention Names

Renvela; Renvela

Eligibility Criteria

Inclusion Criteria

Men or women 18 years of age or older suffering from CKD not on dialysis or on a stable haemodialysis regimen

• If currently on phosphate binder(s), willing to stop this and enter a 2 week washout period
• Willing to avoid any intentional changes in diet such as fasting or dieting
• Have the following laboratory measurement:

• iPTH ≤ 1000 pg/mL at screening (including results obtained within 60 days prior to screening)
• If not taking a phosphate binder, a serum phosphorus measurement >5.5 mg/dL (1.78 mmol/L) at Screening (Visit 1).
• If taking a phosphate binder at screening, a serum phosphorus measurement > 5.5 mg/dL (1.78 mmol/L) after the two-weeks washout period at Visit 1a (Day 0).
• Willing and able to take Sevelamer carbonate alone as a phosphate binder for the duration of the study
• Willing and able to avoid antacids and phosphate binders containing aluminum, magnesium, calcium or lanthanum for the duration of the study
• Willing and able to maintain screening doses of vitamin D, and/or cinacalcet for the duration of the study, except for safety reasons
• If female and childbearing potential (pre-menopausal and not surgically sterile), willing to use an effective contraceptive method throughout study, which includes barrier methods, hormones, or intrauterine devices
• For patients not on dialysis expecting not to initiate dialysis for the duration of this study
• Signed informed consent
• Has not participated in any other investigational drug studies within 30 days prior to enrollment
• Level of understanding and willingness to cooperate with all visits and procedures as described by the study personnel

Exclusion Criteria

• Active dysphagia or swallowing disorder
• Predisposition or current bowel obstruction,
• Severe gastrointestinal (GI) motility disorders including severe constipation
• Active ethanol or drug abuse, excluding tobacco use
• Use of anti-arrhythmic or anti-seizure medications for arrhythmia or seizure disorders.
• In the opinion of the investigator, patient has poorly controlled diabetes mellitus, poorly controlled hypertension, active vasculitis, HIV infection, or any clinically significant unstable medical condition
• Planned renal transplant or parathyroidectomy within 3 months of Visit 1
• Pregnant or breast-feeding
• Evidence of active malignancy except for basal cell carcinoma of the skin
• Unable to comply with the requirements of the study
• Known hypersensitivity to sevelamer or any constituents of the study drug
• Any other condition, which in the opinion of the investigator will prohibit the patient's inclusion in the study

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Genzyme, a Sanofi Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Sciences & Operations

Role: STUDY_DIRECTOR

Sanofi

Locations

Russia

Moscow, , Russia

Countries

Russia

Other Identifiers

U1111-1160-6394

Identifier Type: OTHER

Identifier Source: secondary_id

SVCARB10012

Identifier Type: -

Identifier Source: org_study_id